CLINICAL TRIAL: PNEUMOCOCCAL VACCINE RESPONSE IN COPD

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 慢性阻塞性肺疾病(COPD)是一种影响许多吸烟者的肺部疾病。慢性阻塞性肺疾病患者患细菌感染的风险增加，包括由一种名为肺炎链球菌(肺炎球菌)的细菌引起的感染。肺炎球菌可引起肺炎、脑膜炎、血液感染或COPD加重，这是一种暂时的肺部症状恶化，可能需要住院治疗，并可能危及生命。目前，大多数公共卫生组织建议所有COPD患者以及65岁以上的人接种肺炎球菌疫苗。目前用于成人的疫苗是由23种灭活肺炎球菌制成的胶囊多糖(CPS)疫苗。肺炎球菌几乎有100种，但这23种是成年人感染的最常见原因。接种疫苗会使身体产生抗体，帮助抵御由这23种肺炎球菌引起的肺炎球菌感染。尽管这种疫苗已被证明可以预防年轻、健康的患者的感染，但它对老年患者和那些存在COPD等潜在健康问题的患者似乎效果较差。在过去的几年里，一种新的疫苗被开发出来，称为蛋白质结合疫苗(PCV)。和CPS疫苗一样，卡介苗也是由灭活的肺炎球菌制成的，但它也含有白喉毒素，一种似乎可以增加人体免疫反应的物质。自2000年以来，该疫苗一直用于2岁以下儿童，并在成人身上进行了测试。尽管PCV只由7种肺炎球菌制成，因此不能像CPS疫苗那样对多种细菌提供保护，但一些对70岁以上患者的研究表明，对PCV疫苗的抗体反应可能比CPS疫苗更好。美国食品和药物管理局批准的儿童PCV疫苗剂量为0.5mL，但似乎1.0mL的剂量在成人中可能效果更好。在这项研究中，我们将试图找出在中到重度COPD患者中，1.0毫升的PCV疫苗是否比CPS疫苗具有更好的免疫应答。这项研究由美国国立卫生研究院资助，由马里兰大学医学院的Steven Scharf博士和美国其他九个研究机构的研究人员共同进行。我们计划在马里兰大学招收大约18名患者，在全国范围内招收180名患者。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Chronic Obstructive Pulmonary Disease (COPD) is a disease of the lungs that affects many smokers. Patients with COPD are at increased risk for bacterial infections including those caused by a kind of bacteria named Streptococcus pneumoniae (Pneumococcus). Pneumococcus can cause pneumonia, meningitis, infections of the blood, or COPD ¿exacerbations¿, a temporary worsening of lung symptoms that may require hospitalization and could be life-threatening. At present, most public health organizations recommend that all patients with COPD, as well as anybody over the age of 65, be vaccinated against pneumococcus. The vaccine currently used in adults is the capsular polysaccharide (CPS) vaccine which is made from 23 types of killed pneumococcus. There are almost 100 types of pneumococcus but these 23 are the most common causes of infections in adults. Giving the vaccine causes the body to make antibodies that help fight off pneumococcal infections caused by these 23 types of pneumococcus. Although the vaccine has been shown to prevent infections in young, healthy patients, it appears to be less effective in older patients and in those with underlying medical problems such as COPD. In the last several years, a new vaccine called the protein-conjugate vaccine (PCV) has been developed. Like the CPS vaccine, the PCV is also made from killed pneumococcus but it also contains diphtheria toxin, a substance that appears to increase the body¿s immune response. The vaccine has been used in children under the age of 2 since the year 2000 and has undergone testing in adults. Although the PCV is made from only 7 types of pneumococcus and therefore does not offer protection against as many bacteria as the CPS vaccine, some studies in patients over age 70 suggest that the antibody response to the PCV vaccine may be better than with the CPS vaccine. The Food and Drug Administration approved dose of the PCV vaccine in children is 0.5 mL but it appears that a 1.0 mL dose may work better in adults. In this study, we will try to find out whether 1.0 mL of the PCV vaccine gives a better immune response than the CPS vaccine in patients with moderate to severe COPD. The study is funded by The National Institutes of Health and is conducted by Dr. Steven Scharf from the University of Maryland School of Medicine and researchers from nine other research institutions in the United States. We plan to enroll about 18 patients at the University of Maryland, and 180 patients nationally.